Akorn, Inc.: Drug Recall

Recall #D-1547-2022 · 09/21/2022

Class II: Risk

Recall Details

Recall Number
D-1547-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Akorn, Inc.
Status
Ongoing
Date Initiated
09/21/2022
Location
Gurnee, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,145 bottles

Reason for Recall

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Product Description

Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

Distribution Pattern

USA Nationwide and Puerto Rico

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.